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Safety and immunogenicity of a freeze-dried, Vero cell culture-derived, inactivated Japanese encephalitis vaccine (KD-287, ENCEVAC®) versus a mouse brain-derived inactivated Japanese encephalitis vaccine in children: a phase III, multicenter, double-blinded, randomized trial
DC Field | Value | Language |
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dc.contributor.author | Yun, Ki Wook | - |
dc.contributor.author | Lee, Hoan Jong | - |
dc.contributor.author | Kang, Jin Han | - |
dc.contributor.author | Eun, Byung Wook | - |
dc.contributor.author | Kim, Yae-Jean | - |
dc.contributor.author | Kim, Kyung-Hyo | - |
dc.contributor.author | Kim, Nam Hee | - |
dc.contributor.author | Hong, Young Jin | - |
dc.contributor.author | Kim, Dong Ho | - |
dc.contributor.author | Kim, Hwang Min | - |
dc.contributor.author | Cha, Sung-Ho | - |
dc.date.accessioned | 2015-02-16T01:33:52Z | - |
dc.date.available | 2015-02-16T01:33:52Z | - |
dc.date.issued | 2015-01-08 | - |
dc.identifier.citation | BMC Infectious Diseases. 15:7 | ko_KR |
dc.identifier.uri | https://hdl.handle.net/10371/93790 | - |
dc.description.abstract | Background: Although mouse brain-derived, inactivated Japanese encephalitis vaccines (JE-MBs) have been successfully used for a long time, potential rare neurological complications have prompted the development of a Vero cell culture-derived inactivated vaccine (JE-VC). In a phase III clinical study, we aimed to compare the safety and immunogenicity of a JE-VC, KD-287 with a JE-MB, JEV-GCC, in children.
Methods: In this multicenter, double-blinded, randomized controlled trial, the study population consisted of 205 healthy Korean children aged 12–23 months. Each subject was subcutaneously vaccinated with either KD-287 or JEV-GCC twice at an interval of 2 weeks and then vaccinated once 12 months after the second vaccination. Neutralizing antibodies were measured by the plaque reduction neutralization test using the homologous and heterologous, as a post hoc analysis, challenge virus strains. Results: The three-dose regimen of KD-287 showed a comparable safety profile with JEV-GCC except higher incidence of fever after the first dose (30.4% and 14.7%, respectively). Most of the fever was mild degree (61.3% and 66.7%, respectively). KD-287 fulfilled the non-inferiority criteria for seroconversion rate (SCR) and geometric mean titer (GMT) of the neutralizing antibody, which were the primary endpoints, at 4 weeks after the third vaccination (95% CI: −1.00, 3.10 for the SCR difference and 10.8, 17.6 for the GMT ratio). The SCRs of KD-287 were all 100% and the GMTs were higher in the KD-287 group than in the JEV-GCC group after the second vaccination and before and after the third vaccination (GMT ratio: 5.59, 20.13, and 13.79, respectively, p < 0.001 in all). GMTs were higher in the KD-287 group in the heterologous analysis also (GMT ratio: 4.05, 5.15, and 4.19, respectively, p < 0.001 in all). Conclusions: This study suggests that the KD-287, a JE-VC is as safe as and may be more effective than the licensed MB-derived vaccine. KD-287 could thus be useful as a second-generation vaccine and substitute for the current JE-MB vaccine in Korean children. | ko_KR |
dc.language.iso | en | ko_KR |
dc.publisher | BioMed Central | ko_KR |
dc.subject | Japanese encephalitis | ko_KR |
dc.subject | Vaccine | ko_KR |
dc.subject | Vero cells | ko_KR |
dc.subject | Clinical trial | ko_KR |
dc.title | Safety and immunogenicity of a freeze-dried, Vero cell culture-derived, inactivated Japanese encephalitis vaccine (KD-287, ENCEVAC®) versus a mouse brain-derived inactivated Japanese encephalitis vaccine in children: a phase III, multicenter, double-blinded, randomized trial | ko_KR |
dc.type | Article | ko_KR |
dc.contributor.AlternativeAuthor | 윤기욱 | - |
dc.contributor.AlternativeAuthor | 이환종 | - |
dc.contributor.AlternativeAuthor | 강진한 | - |
dc.contributor.AlternativeAuthor | 은병욱 | - |
dc.contributor.AlternativeAuthor | 김예진 | - |
dc.contributor.AlternativeAuthor | 김경효 | - |
dc.contributor.AlternativeAuthor | 김남희 | - |
dc.contributor.AlternativeAuthor | 홍영진 | - |
dc.contributor.AlternativeAuthor | 김동호 | - |
dc.contributor.AlternativeAuthor | 김황민 | - |
dc.contributor.AlternativeAuthor | 차성호 | - |
dc.identifier.doi | 10.1186/s12879-014-0744-4 | - |
dc.language.rfc3066 | en | - |
dc.description.version | Peer Reviewed | - |
dc.rights.holder | Ki Wook Yun et al.; licensee BioMed Central Ltd. | - |
dc.date.updated | 2015-01-16T12:15:52Z | - |
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